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Call key data
Development and harmonisation of methodologies for assessing digital health technologies in Europe
|Funding Program||Horizon Europe - Cluster 1 - Destination 6: Maintaining an innovative, sustainable and globally competitive health industry|
|Call budget||€ 15,000,000.00|
|Estimated EU contribution per project||between € 7,000,000.00 and € 8,000,000.00|
|Link to the call||ec.europa.eu|
|Link to the submission||ec.europa.eu|
The proposals are expected to develop and harmonise methodologies for assessing digital health technologies (including mhealth apps and telehealth, as well as Artificial Intelligence powered health technologies) in order to facilitate assessment of their added value at individual, health system and society levels and facilitate the cross-border deployment of digital health services within the EU.
Digital health technologies have been driving a revolution in health and care ranging from general use of computers to algorithms designed to assist radiologists and radiotherapists in detecting and treating diseases, from robotic surgery to artificial intelligence, machine learning, computer aided decision models, and from mobile apps helping patients to self-manage their disease to electronic health records.
Digital health technologies are expected to further contribute to better people-centred health and care systems and have the vast potential to improve our ability to accurately prevent, diagnose and treat diseases.
However, assessing the added value and health benefits for patients and society pose a number of challenges in particular of methodological and technical nature. Best practice for common approaches in methodology for digital health are lacking, especially in the digital health tools that include artificial intelligence algorithms. A framework for the assessment of the digital transformation of health services and its impact is vital to generate the evidence required for decision-making on stimulating, using and/or funding digital health strategies at various levels in the health and care systems.
The Expert Panel on effective ways of investing in Health (EXPH) recommended in its report ‘Assessing the impact of digital transformation of health services’, further investment in the development of assessment methodologies and in a European repository for evaluation methods and evidence of digital health services.
To date, such assessment frameworks are relatively scarce, especially those addressing the transformative aspects of healthcare delivery on the organisational and operational level.
Existing Health Technology Assessment (HTA) methodology is well developed for health technologies such as medicinal products, but also for some categories of medical devices; however digitalisation raises new methodological challenges to the standardisation of assessment criteria such as privacy, cybersecurity, data storage and handling, interoperability, usability etc. Also including aspects like learning curves, iterative development of innovations, variability between settings, determining optimal timing of evaluations in the development process (maturity) are not yet solved.
Proposals are expected to build on existing frameworks such as (but not restricted to) ‘Model for Assessment of Telemedicine’ (MAST framework – Kidholm et al., 2012) and the results of previous EU-funded projects in particular (but not restricted to) COMED, project that already identified HTA challenges of telehealth and mhealth, and mHealth hub.
Proposals should consider involving the JRC to take advantage of its expertise on assessment frameworks of innovative health technologies and its activities at the interface between research and regulatory aspects and/or in translating assessment results into best practice recommendations anchored in EU policies. In that respect, the JRC is open to collaborate with any successful proposal after its approval.
The proposals should address all of the following activities:
Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.
|Expected effects and impacts|
|Regions / countries for funding||EU Member States, Overseas Countries and Territories (OCT)|
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Island (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), Morocco (المغرب), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom
|eligible entities||EU Body, Education and training institution, International organization, Natural Person, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)|
To be eligible for funding, applicants must be established in one of the following countries:
Applications may be submitted by one or more legal entities, which may be established in a Member State, Associated Country or, in exceptional cases and if provided for in the specific call conditions, in another third country.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.
Any legal entity, regardless of its place of establishment, including legal entities from non-associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call topic.
A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.
The Joint Research Centre (JRC) may participate as member of the consortium selected for funding.
Digitalisation, Digital Society, ICT,
Health, Social Services, Sports
|Relevance for EU Macro-Region||EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region|
|UN Sustainable Development Goals (UN-SDGs)|
All proposals must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.
Proposals must be complete and contain all parts and mandatory annexes and supporting documents, e.g. plan for the exploitation and dissemination of the results including communication activities, etc.
The application form will have two parts:
Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).
The limit for a full application (Part B) is 45 pages.
The award criteria are described in General Annex D. The following exceptions apply: The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
The rules for the legal and financial set-up of the grant agreements are described in General Annex G. The following exceptions apply: In order to optimise synergies and increase the impact of the projects, all projects selected for funding from this topic will form a cluster and be required to participate in common networking and joint activities (and in determining modalities for their implementation and the specific responsibilities of projects). Depending on the scope of proposals selected for funding, these activities may include:
|Call documents|| HE-Work Programme 2023-2024, Cluster 1, Destination 6 (452kB)
|Contact||National Contact Points for Horizon Europe |
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